Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-31 @ 7:44 PM
Study NCT ID:
NCT01884961
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2013-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiotherapy As an Immunological Booster in Patients with Metastatic Melanoma or Renal Cell Carcinoma Treated with High-dose Interleukin-2
Sponsor:
Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
Organization:
Study Overview
Official Title:
Radiotherapy As an Immunological Booster in Patients with Metastatic Melanoma or Renal Cell Carcinoma Treated with High-dose Interleukin-2: Evaluation of Biomarkers of Immunologic and Therapeutic Response
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IL2HD
Brief Summary:
Title: Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
Phase: Proof of Principle phase II study
Study Design: Single center, open-label trial to assess the immune response and potential biomarkers predictive of response
Study Duration:
Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up every three months
Number of Subjects:
Mini-max two-stage Simon design:
• Step 1: 7 patients enrolled
If tumor antigen-specific immune response is observed in at least 3 patients:
• Step 2: recruitment of an additional 12 patients
Phase: Proof of Principle phase II study
Study Design: Single center, open-label trial to assess the immune response and potential biomarkers predictive of response
Study Duration:
Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up every three months
Number of Subjects:
Mini-max two-stage Simon design:
• Step 1: 7 patients enrolled
If tumor antigen-specific immune response is observed in at least 3 patients:
• Step 2: recruitment of an additional 12 patients
Detailed Description:
Title: Radiotherapy as an immunological booster in patients with metastatic melanoma or renal cell carcinoma treated with High-dose Interleukin-2: evaluation of biomarkers of immunologic and therapeutic response
Phase: Proof of Principle phase II study
Study Design: Single center, open-label trial to assess the immune response and potential biomarkers predictive of response
Study Duration:
Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up every three months
Primary objectives:
1. to determine the tumor antigen-specific immune response induced by the treatment
2. to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy
Secondary end points:
1. Toxicity
2. Response Rate
3. Overall Survival.
Number of Subjects:
Mini-max two-stage Simon design:
• Step 1: 7 patients enrolled
If tumor antigen-specific immune response is observed in at least 3 patients:
• Step 2: recruitment of an additional 12 patients
Study Product, Dose, Route, Regimen and duration of administration:
Three daily doses boost radiotherapy (XRT) at 6-12 Gy to at least 1, and up to a maximum of 5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of IL-2. The first day of administration of IL-2 of each cycle is the day +1.
Treatment with IL-2 (dose 18 MIU/m2/day in 500cc by continuous IV infusion for 72 hours) will start on day +1 and will be administered every 3 weeks up to 4 cycles, than every 3-4 weeks for a further 2 cycles.
IL-2 will be withheld for refractory hypotension (hypotension where isotropic or vasoactive therapy is ineffective and that persists despite specific medical therapy set), anuria for \> 24 hours, respiratory distress, confusion, sustained ventricular tachycardia, signs of myocardial ischemia or myocarditis, persistant metabolic acidosis, atrial fibrillation and documented systemic infection.
Patients will be evaluated every 8 weeks with computed tomography to determine the response, and every 3 months after completion of treatment until death (the time of disease progression and the initiation of alternative therapies will also be documented).
Statistical Methodology:
A minimax two-stage Simon design will be employed. A 40% immune response will preclude further study, whereas a 70% response rate will indicate that further study would be warranted. Using alfa and beta errors of 0.10, 7 patients will be enrolled during the first stage, and if an immune response is observed in at least 3 patients the study will go on, and an additional 12 patients will be treated. The treatments will be considered active if a tumor antigen-specific immune response is observed in 11 out of 19 patients treated. The analysis will be performed on an intention to treat population, i.e. all patients having received at least one cycle of therapy.
Phase: Proof of Principle phase II study
Study Design: Single center, open-label trial to assess the immune response and potential biomarkers predictive of response
Study Duration:
Total duration: 36 months Enrollment: 20 months Treatment: 5 months per patient Follow-up every three months
Primary objectives:
1. to determine the tumor antigen-specific immune response induced by the treatment
2. to prospectively determine the predictive/prognostic value of pretreatment biological features in identifying patients who will benefit from HDIL-2-based therapy
Secondary end points:
1. Toxicity
2. Response Rate
3. Overall Survival.
Number of Subjects:
Mini-max two-stage Simon design:
• Step 1: 7 patients enrolled
If tumor antigen-specific immune response is observed in at least 3 patients:
• Step 2: recruitment of an additional 12 patients
Study Product, Dose, Route, Regimen and duration of administration:
Three daily doses boost radiotherapy (XRT) at 6-12 Gy to at least 1, and up to a maximum of 5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of IL-2. The first day of administration of IL-2 of each cycle is the day +1.
Treatment with IL-2 (dose 18 MIU/m2/day in 500cc by continuous IV infusion for 72 hours) will start on day +1 and will be administered every 3 weeks up to 4 cycles, than every 3-4 weeks for a further 2 cycles.
IL-2 will be withheld for refractory hypotension (hypotension where isotropic or vasoactive therapy is ineffective and that persists despite specific medical therapy set), anuria for \> 24 hours, respiratory distress, confusion, sustained ventricular tachycardia, signs of myocardial ischemia or myocarditis, persistant metabolic acidosis, atrial fibrillation and documented systemic infection.
Patients will be evaluated every 8 weeks with computed tomography to determine the response, and every 3 months after completion of treatment until death (the time of disease progression and the initiation of alternative therapies will also be documented).
Statistical Methodology:
A minimax two-stage Simon design will be employed. A 40% immune response will preclude further study, whereas a 70% response rate will indicate that further study would be warranted. Using alfa and beta errors of 0.10, 7 patients will be enrolled during the first stage, and if an immune response is observed in at least 3 patients the study will go on, and an additional 12 patients will be treated. The treatments will be considered active if a tumor antigen-specific immune response is observed in 11 out of 19 patients treated. The analysis will be performed on an intention to treat population, i.e. all patients having received at least one cycle of therapy.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-001786-32 | EUDRACT_NUMBER | None | View |